CN115089347A

CN115089347A - Heart valve graft

Info

Publication number: CN115089347A
Application number: CN202210721969.2A
Authority: CN
Inventors: 左辉; 夏小三
Original assignee: Beijing Xinwei Medical Technology Co ltd
Current assignee: Beijing Xinwei Medical Technology Co ltd
Priority date: 2022-06-24
Filing date: 2022-06-24
Publication date: 2022-09-23

Abstract

The invention relates to the technical field of medical equipment, and discloses a heart valve graft, which comprises a valve stent and artificial valve leaflets positioned inside the valve stent, wherein the valve stent comprises: a stent body; the first limiting part is arranged at the proximal end of the bracket main body and is used for limiting the valve bracket to move towards the distal end when the valve bracket is in a working state; the second limiting part is arranged at the far end of the support main body and is used for limiting the valve support to move towards the near end when the valve support is in a working state. The heart valve graft finishes the operation by the approach transportation of peripheral arterial blood vessels such as femoral artery and the like, has the functions of treating aortic stenosis and regurgitation, has anchoring limit at the proximal end and the distal end, has stronger anchoring property of a valve clamp when being used for a pure regurgitation case, can also fix a self-valve, and reduces the risk of coronary artery opening obstruction.

Description

Heart valve graft

Technical Field

The invention relates to the technical field of medical equipment, in particular to a heart valve graft which is suitable for treating pure reflux disease and leaflet calcification insufficiency disease.

Background

In the middle-aged and elderly, the prevalence of aortic valve disease reaches 3%. Common aortic valve diseases include aortic regurgitation and aortic stenosis, which have a very poor prognosis after onset, with a two-year survival rate of less than 50% and a five-year survival rate of only 20%. At present, the lower valve replacement operation of the surgical thoracotomy is an effective treatment method, but patients cannot bear the traditional surgical thoracotomy operation due to the old age, more complications and poor left heart function. Transcatheter Aortic Valve Replacement (TAVR) is not required to be performed by an open chest surgery, and the artificial aortic valve is implanted into a human body in a transcatheter manner, so that the purpose of minimally invasive valve replacement is achieved. Compared with the traditional surgical operation, the technology has the advantages of being more minimally invasive, faster in postoperative recovery, high in patient tolerance and the like, and provides an effective and safer treatment means for patients who are contraindicated or at high risk in the surgical operation.

Although TAVR is currently becoming mature, technical problems remain for some special cases, such as:

(1) the current TAVR valve products for transfemoral approach rely solely on calcified leaflets to achieve support of the product, but for patients without calcified leaflets, there are difficulties in positioning and anchoring, resulting in the risk of valve displacement. For the patients, no TAVR valve which is accessed through the artery is on the market at home and abroad.

(2) Patients with partial valve leaflet calcification, presenting with verbosity and thickening of the autologous diseased valve, have a risk of the autologous diseased valve obstructing the coronary opening during TAVR procedures, and if the calcified valve leaflets are simply squeezed, once the coronary opening is obstructed, acute myocardial infarction is caused and life-threatening, and many patients are therefore not successful in TAVR.

(3) The main application symptom of the existing artificial heart prosthesis with the valve clip is the artificial heart valve which is in simple backflow, but for a patient caused by calcification of valve leaflets, the calcified human valve leaflets can cause the arc bottoms of the valve clip not to be on the same plane, so that the valve implant is inclined, and serious paravalvular leakage can be caused, so that treatment failure can occur.

(4) The current products have perivalvular leakage probability after surgery.

Accordingly, there is a need to provide an ideal TAVR valve system that can be adapted to perform TAVR procedures via arterial access with minimal surgical trauma, and that can simultaneously provide treatment for aortic valve regurgitation and stenosis.

Disclosure of Invention

In order to solve the above problems, embodiments of the present invention provide a heart valve graft including a valve stent and a prosthetic leaflet located inside the valve stent, the valve stent including: a stent body; the first limiting piece is arranged at the proximal end of the bracket main body and is used for limiting the valve bracket to move towards the distal end when the valve bracket is in a working state; the second limiting part is arranged at the far end of the support main body and is used for limiting the valve support to move towards the near end when the valve support is in a working state.

In some embodiments of the invention, the stent body comprises at least one first connecting portion, the second retaining member comprises a valve clip, the valve clip comprises at least one second connecting portion and at least one clamping portion, the first and second connecting portions are configured to be detachably connected, and the clamping portion is configured to restrain a human leaflet between the stent body and the valve clip when the valve stent is in an operating state.

In some embodiments of the present invention, the bracket main body includes a connector, and the first connection part and the second connection part are detachably connected by the connector.

In some embodiments of the present invention, the first connecting portion and the second connecting portion are each an elastic opening deformation member having a protrusion, the connecting member is a sleeve, the sleeve has a through receiving cavity, and a distal end of the sleeve extends to form a bendable limiting portion, the receiving cavity is configured to allow the protrusion of the first connecting portion and the protrusion of the second connecting portion to pass through after being deformed, the protrusion is configured to limit movement of the connecting member, and the limiting portion is configured to limit deformation of the elastic opening of the first connecting portion and the elastic opening of the second connecting portion after being bent.

In other embodiments of the present invention, the first connecting portion is provided with a first hole, the second connecting portion is provided with a second hole, and the connecting member is a suture or a metal buckle which can pass through the first hole and the second hole.

In some embodiments of the invention, a clamping reinforcement member is disposed in the center of the clamping portion of the valve clamp, the clamping reinforcement member has a connecting end and a free end, the connecting end of the clamping reinforcement member is fixedly connected to the clamping portion, the free end of the clamping reinforcement member extends from the clamping portion to the far end of the stent, and the clamping reinforcement member is configured to clamp the human valve leaflet to the outside of the stent body when the valve stent is in an operating state.

In some embodiments of the invention, a bottom of the clamping portion of the valve clip includes a recess configured to clamp the body valve leaflet to an exterior of the stent body when the valve stent is in an operational state.

In some embodiments of the present invention, the second retaining member includes at least one retaining rod, the retaining rod has a connecting end and a free end, the connecting end is fixedly connected to the stent main body, and the free end extends outward from the stent main body so that the retaining rod axially presses against the human valve leaflet when the valve stent is in the working state. For example, the free end of the limiting rod is provided with barbs, and the barbs are arranged to be suitable for clamping the valve leaflets of the human body when the valve support is in the working state.

In some embodiments of the present invention, the first retaining member includes a plurality of supporting members, the supporting members are disposed along a circumferential direction of the stent body and fixedly connected to the stent body, the supporting members are configured to be deployed outward from the stent body to limit the valve stent from moving to a distal end when the valve stent is in the working state, and an encryption rod fixedly connected to the stent body is disposed between adjacent supporting members.

In some embodiments of the invention, the distal end of the stent body is provided with an interface for gripping by a delivery system.

In some embodiments of the invention, the bottom of the clamping portion of the valve clip is provided with a through hole, and the through hole is filled with a developing material.

Because the second locating part comprises a detachable valve clamp and a locating rod, whether the valve clamp is used or not can be selected according to needs in actual use so as to aim at different diseases. For example, when used to treat pure regurgitation conditions, the use of a full valve clip may be retained; when the valve holder is used for treating the insufficiency caused by the calcification of the valve leaflets, whether the valve holder is reserved or not can be selected according to the actual situation, for example, when a patient suffering from severe calcification is encountered, the valve holder can influence the positioning of a valve stent, the valve holder is not reserved, and the valve graft is prevented from moving only by the limiting rod and the first limiting piece.

The aortic valve graft has the advantages that the delivery path can be used for completing the operation through the approach of peripheral arterial blood vessels such as femoral artery and the like, the aortic valve graft has the functions of treating aortic stenosis and regurgitation, and has anchoring and limiting functions at the proximal end and the distal end.

Various aspects, features, advantages, etc. of embodiments of the invention are described in detail below with reference to the accompanying drawings. The above aspects, features, advantages, etc. of the present invention will become more apparent from the following detailed description when taken in conjunction with the accompanying drawings.

Drawings

Fig. 1 is a schematic perspective view of a heart valve graft according to example 1 of the invention.

Fig. 2 is a schematic cross-sectional view showing the heart valve graft of fig. 1 positioned in a blood vessel.

Figure 3A is a schematic diagram showing the sleeve, valve clip connection portions, and corresponding connection sites of the stent body of the heart valve graft of figure 1.

Fig. 3B is a schematic view of the sleeve, the valve clip connecting portion, and the stent main body of fig. 3A, showing the connection manner of the corresponding connecting portions.

Fig. 4 is a schematic cross-sectional view of a heart valve graft according to example 2 of the present invention in a blood vessel.

Fig. 5 is a schematic diagram illustrating a valve clip of the heart valve graft of fig. 4.

Fig. 6A and 6B are schematic views of two attachment ways of the valve clip and the valve stent of the heart valve graft shown in fig. 4.

Figure 7 is a schematic cross-sectional view of a heart valve graft according to example 3 of the invention in a blood vessel.

Fig. 8 is a top schematic view illustrating a valve clip of the heart valve graft of fig. 7.

Fig. 9 is a schematic perspective view of a heart valve graft according to example 4 of the invention.

Fig. 10 is a schematic diagram illustrating a valve clip of the heart valve graft of fig. 9.

Fig. 11 is a schematic cross-sectional view of the heart valve graft of fig. 9 in a blood vessel.

Figure 12 is a schematic view of another embodiment of a valve clip.

Fig. 13 is a schematic perspective view of a valve clip of a heart valve graft according to example 5 of the invention.

Detailed Description

To facilitate an understanding of the various aspects, features and advantages of the present inventive subject matter, reference is made to the following detailed description taken in conjunction with the accompanying drawings. It is to be understood that the following embodiments are illustrative only and not intended to limit the scope of the present invention, and that various combinations may be made without departing from the spirit of the invention.

Embodiments of the present invention provide a heart valve graft comprising a valve stent and prosthetic leaflets located inside the valve stent, the valve stent comprising: a stent main body; the first limiting piece is arranged at the proximal end of the bracket main body and is used for limiting the valve bracket to move towards the distal end when the valve bracket is in a working state; the second limiting part is arranged at the far end of the support main body and is used for limiting the valve support to move towards the near end when the valve support is in a working state.

In embodiments of the invention, there are a variety of designs for the valve clip and retainer, and various embodiments are given below.

[ example 1 ]

The heart valve graft of example 1 of the present invention will be specifically described below with reference to fig. 1 to 3B. Fig. 1 is a schematic perspective view of a heart valve graft according to example 1 of the invention; FIG. 2 is a schematic cross-sectional view showing the heart valve graft of FIG. 1 positioned in a blood vessel; FIG. 3A is a schematic diagram showing the sleeve, valve clip connection portions, and corresponding connection sites of the stent body of the heart valve graft of FIG. 1; fig. 3B is a schematic perspective view of the sleeve, the valve clip connecting portion, and the connecting manner of the corresponding connecting portions of the stent main body.

As shown in fig. 1 and 2, the heart valve graft 1 includes a valve stent 11 and a prosthetic leaflet 12 located inside the valve stent 11. The valve stent 11 may be an outer covering membrane, which is not shown for the sake of illustration. The valve stent 11 includes a stent main body 111, a first limiting member and a second limiting member, the stent main body 111 has an internal channel in a deployed state, the artificial valve leaflet 12 is connected in the internal channel, the first limiting member is disposed at a proximal end of the stent main body 111 and configured to limit the valve stent from moving to the distal end when the valve stent is in a working state, the first limiting member can also play a role in sealing, and the second limiting member is disposed at the distal end of the stent main body and configured to limit the valve stent from moving to the proximal end when the valve stent is in the working state.

In this embodiment, the second limiting member includes a valve clip 112 and a limiting rod 113 disposed at the distal end of the stent body. Wherein the valve clip 112 is an integrally formed valve clip that is detachably connected to the holder body 111. Specifically, the stent main body 111 includes 3 first connecting portions 1111, the valve clip includes 3 connecting

portions

1121 and 3 clamping portions 1122, the second connecting portions 1121 correspond to the first connecting portions 1111 and are detachably connected therebetween so as to detachably connect the valve clip to the stent main body 111, and the clamping portions 1122 are provided to restrain the human valve leaflet between the stent main body and the valve clip when the valve stent is in the working state. In this embodiment, the clamping portions 1122 are V-shaped, each clamping portion has an arc bottom located at the proximal end and a pair of top ends extending from the arc bottom to the distal end, the top ends of adjacent clamping portions are connected to form an arc top, and the second connecting portion 1121 is disposed on the arc top and extends to the distal end. In this embodiment, the first connection portions 1111 are uniformly distributed along the circumferential direction of the stent body, the second connection portions 1121 correspond to the first connection portions 1111, and the 3 clamping portions 1122 are V-shaped clips with the same size. In an alternative embodiment, the first connecting portions 1111 may not be uniformly distributed, and the clamping portions 1122 may be changed in size according to actual needs.

In this embodiment, the bracket main body further includes a connection member, and the first connection portion 1111 and the second connection portion 1121 are detachably connected by the connection member. As shown in fig. 3A to 3B, the first connection portion 1111 and the second connection portion 1121 are both elastic opening deformation pieces, the connection piece is a sleeve 116, the sleeve has a through accommodation cavity 1161, and the distal end of the sleeve extends to form a bendable limiting portion 1162. The first connection portion 1111 has a protrusion 1113 at the opening and a protrusion 1114 near the connection portion, the second connection portion 1121 is also provided with a protrusion corresponding to the first connection portion, i.e., a protrusion 1123 at the opening and a protrusion 1124 near the connection portion, the receiving cavity 1161 of the sleeve is configured to allow the

protrusions

1113 and 1123 of the first connection portion 1111 and the second connection portion 1121 to pass through after being deformed, the

protrusions

1113 and 1123 of the first connection portion 1111 and the second connection portion 1121 pass through the receiving cavity and then elastically release the catch outside of the sleeve again so that the

protrusions

1113 and 1123 restrict the sleeve 116 from moving toward the distal end, the

protrusions

1114 and 1124 restrict the sleeve 116 from moving toward the proximal end, and the stopper 1162 of the sleeve 116 is configured to catch at the elastic opening of the first connection portion 1111 and the second connection portion 1121 after being bent to restrict the elastic opening from being deformed again. The valve clip 112 is detachably connected to the holder main body 111 by inserting the protruding openings of the first connection portion 1111 and the second connection portion 1121 into the sleeve 116 by biased deformation and bending the stopper portion 1162 and catching it at the openings of the connection portions. In alternative embodiments, the connection member may be another member that can detachably connect the first connection portion 1111 and the second connection portion 1121, for example, a suture, a metal ring, a rubber ring, or the like, and the first connection portion 1111 and the second connection portion 1121 may also be elastic members with other shapes, and the movement of the connection member may also be limited in other manners.

In practical use, the sleeve 116 is fitted on the second connecting portion 1121 of the valve clip, and whether to mount the valve clip can be selected according to requirements; when the valve clip needs to be installed, the first connecting portion 1111 of the bracket component is squeezed into the accommodating cavity of the sleeve through external force bias, and then the limiting portion 1161 of the sleeve is bent to clamp the first connecting portion and the second connecting portion so as to prevent the sleeve from loosening.

In this embodiment, 3 limiting rods 113 are located at the "large opening" of the stent body for reserving the passage for the subsequent coronary procedure, and each limiting rod 113 comprises a connecting end 1131 and a free end 1132, the connecting end is fixedly connected with the stent body, and the free end is extended outwards from the stent body 111 so that the limiting rods 113 are suitable for axially pressing against the valve leaflets of the human body when the valve stent is in the working state. Thus, the stop rod 113 can form a hook-like structure at the "large opening" of the stent body, as shown in fig. 2, when encountering a leaflet of a human body, the stop rod 113 can press the leaflet to prevent the stent from moving towards the ventricle (proximal end). In an alternative embodiment, the free end of the stop rod may be further provided with barbs configured to catch the body leaflets when the valve stent is in the working state to further prevent the stent from moving toward the ventricle (proximal end). In this embodiment, 3 limiting rods 113 are uniformly distributed along the circumferential direction of the stent main body, the limiting rods 113 are in an inverted V shape, and have connecting ends 1131 which are arranged in pairs and fixedly connected with the stent main body and free ends 1132 which extend from the connecting ends 1131 to the distal end and obliquely extend to the outside of the stent main body 111, and the free ends 1132 have an arc design to avoid scratching the leaflets of the human body.

Since the valve clip is detachably connected to the holder main body, whether to use the valve clip can be selected as desired. When the valve clip is reserved for use, the valve graft can be used for treating pure reflux disease and can also be suitable for incomplete closing disease of valve leaflet calcification; when the valve clip is not used separately from the stent body, the valve graft may be better suited for a insufficiency condition in which the leaflets are calcified.

In the present embodiment, the first limiting member includes a plurality of supporting members 114 and a plurality of encryption rods 115. Referring to fig. 1-2, a support 114 is disposed circumferentially of the stent body and is fixedly attached to the stent body 111, and is configured to expand outwardly from the stent body 111 to limit distal movement of the valve stent when the valve stent is in a released state, and can be used to support a sealing skirt (not shown). Therefore, the valve stent can be effectively prevented from moving towards the aorta direction (the far end), and the perivalvular leakage can be effectively reduced or eliminated. In an alternative embodiment, an encryption rod 115 fixedly connected with the bracket main body 111 is further disposed between the adjacent supporting pieces 114 to increase the sealing effect.

The distal end of the stent body is further provided with an interface portion 1112 for gripping by the delivery system, where a first connection portion 1111 may be provided. The connector part is in an inverted V shape and is provided with connecting ends which are arranged in pairs and fixedly connected with the support main body and free end arc tops which extend from the connecting ends to the far end, and the arc tops of the connector part are inwards sunken so as to avoid the contact of the top end of the support and ascending aorta and the stimulation of blood vessels.

The framework structure of the valve graft composed of the stent main body 111, the limiting rod 113, the supporting member 114 and the encrypted rod 115 is integrally formed, for example, by laser cutting using stainless steel or nitinol elastic material. Alternatively, at least any two of the stopper rod 113, the support 114, the encryption lever 115, and the holder main body 111 are integrally formed. The integral formation can reduce the outer diameter of the valve graft in a compressed state for delivery, facilitating introduction into a blood vessel. In other embodiments, the support, stop bar, etc. may be fixedly connected to the stent body in other ways. For example, the stopper is fixed to the holder main body by welding.

[ example 2 ]

The heart valve graft according to example 2 of the present invention will be specifically described below with reference to fig. 4 to 6B. Fig. 4 is a schematic cross-sectional view of a heart valve graft according to example 2 of the present invention in a blood vessel; fig. 5 is a schematic view showing a valve clip of the heart valve graft shown in fig. 4; fig. 6A and 6B are schematic views of two attachment methods of the valve clip to the valve holder.

The heart valve graft 2 in this embodiment differs from the heart valve graft 1 in embodiment 1 mainly in the detachable connection between the valve clip and the stent body.

As shown in fig. 4, the heart valve graft 2 includes a valve stent 21 and a prosthetic leaflet 22 located inside the valve stent 21. The valve stent 21 includes a stent main body 211, a first stopper (a plurality of supports 214 and a plurality of encryption rods 215), and a second stopper (a valve clip 212 and a stopper rod 213). The stent main body 211 has an inner passage in the deployed state, and the artificial leaflet 22 is attached in the inner passage.

In this embodiment, the valve clip 212 is an integrally formed valve clip that is removably attached to the stent body 111. Specifically, the frame body 211 includes 3 first connecting portions 2111, the valve clip includes 3 second connecting

portions

2121 and 3 clamping portions 2122, the second connecting portions 2121 correspond to the first connecting portions 2111 and are detachably connected to detachably connect the valve clip to the frame body 211, and the clamping portions 2122 are configured to trap the human valve leaflets between the frame body and the valve clip when the valve frame is in an operating state. In this embodiment, the clamping portions 2122 are all in a V shape, each of the clamping portions has an arc bottom located at the proximal end and a pair of top ends extending from the arc bottom to the distal end, the top ends of adjacent clamping portions are connected to form an arc top, and the second connecting portion 2121 is disposed on the arc top and extends to the distal end. In this embodiment, the first connecting portions 2111 are uniformly distributed along the circumferential direction of the stent body, the second connecting portions 2121 correspond to the first connecting portions 1111, and the 3 clamping portions 2122 are V-shaped clamps having the same size. In an alternative embodiment, the first connection portions 2111 may be unevenly distributed, and the clamping portion 2122 may be changed in size according to actual needs.

Wherein each of the first connection portions 2111 is provided with a first hole 2112, each of the second connection portions is provided with a second hole 2123, and the first connection portion and the second connection portion are detachably connected by a connection member. For example, the connecting member is a suture thread that can be passed through the first hole and the second hole, and the first connecting portion and the second connecting portion are sewn together by passing the suture thread through the first hole and the second hole (as shown in fig. 6A). In an alternative embodiment, the connector is a metal ring that can pass through the first hole and the second hole, and the metal ring is used to pass through the first hole 2112 and the second hole 2123 to allow the valve clip to be snapped into the holder body, i.e., the notched metal ring is sleeved on the first hole and the second hole and then an external force is applied to close the notch of the metal ring (as shown in fig. 6B). Thus, if the valve implant is provided with the detachable valve clip when being delivered from the factory, the valve clip is convenient to detach, and the valve clip can be detached on the operation site as required; or if the valve clip and the stent main body are separated in the factory, the corresponding first hole and second hollow design also enables the valve clip to be easily installed in the operation field.

In this embodiment, as shown in fig. 5, the bottom of the clamping portion of the valve clip includes a recessed portion 2124 that is concave towards the stent body and is configured to clamp the body leaflets to the outside of the stent body when the valve stent is in the working state. The concave part can concentrate most of force to the bottom of the valve leaf, so that the clamping force can be increased, the human valve leaf can tightly wrap the outer part of the bracket main body, and the valve leakage is reduced.

[ example 3 ] A method for producing a polycarbonate

The heart valve graft according to example 3 of the present invention will be specifically described below with reference to fig. 7 to 8. Fig. 7 is a schematic cross-sectional view of a heart valve graft according to example 3 of the present invention in a blood vessel, and fig. 8 is a schematic top view of the heart valve graft.

The heart valve graft 3 in this embodiment differs from the heart valve graft 1 in embodiment 1 mainly in that the use of a valve clip is omitted. The valve stent 31 may be an outer covering membrane, which is not shown for the sake of illustration.

As shown in fig. 7, the heart valve graft 3 includes a valve stent 31 and a prosthetic leaflet 32 located inside the valve stent 31. The valve stent 31 includes a stent main body 311, a first limiting member and a second limiting member, wherein the first limiting member includes a plurality of supporting members 313 and a plurality of encryption rods 314, and the second limiting member includes 3 limiting rods 312. The stent main body 311 has an inner passage in the deployed state, and the artificial leaflet 32 is connected in the inner passage.

In this embodiment, the use of the valve clip is omitted, leaving only the design of the stop bar. The limiting rod 312 comprises a connecting end and a free end, the connecting end is fixedly connected with the support main body 311, and the free end extends outwards from the support main body 311 so that the limiting rod 312 radially extends and axially supports against the human valve leaflets when the valve support is in a working state. As shown in fig. 7, the free ends of the retaining members are provided with barbs 3121 configured to catch the leaflets of the body when the valve stent is in an operating state, so that when calcified body leaflets (region a) are encountered, the retaining rods 312 hang on the leaflets, securing the stent against movement toward the ventricle (proximal end). In an alternative embodiment, the design of the barbs may also be omitted.

Since the valve clip is detachably connected to the stent body, whether to use the valve clip can be selected as desired. When the valve clip remains in use, the valve graft may be suitable for conditions of insufficiency of calcification of the leaflets, in addition to conditions of pure regurgitation; when the valve clamp is separated from the main support body and is not used, the valve graft can be better suitable for incomplete closing disease of valve leaflet calcification, at the moment, the outward expansion of the support part plays a role in sealing and preventing the valve graft from moving towards the direction of an aorta, and the limiting rod plays a role in preventing the valve graft from moving towards the direction of a ventricle.

[ example 4 ] A method for producing a polycarbonate

The heart valve graft of example 4 of the present invention will be specifically described below with reference to fig. 9 to 12. Fig. 9 is a schematic perspective view of a heart valve graft according to example 4 of the invention; FIG. 10 is a schematic view showing a valve clip of the heart valve graft of FIG. 9; FIG. 11 is a schematic cross-sectional view of the heart valve graft of FIG. 9 in a blood vessel; figure 12 is a schematic view of another embodiment of a valve clip.

The heart valve graft 4 in this embodiment differs from the heart valve graft 1 in embodiment 1 mainly in the design of the valve clip.

As shown in fig. 9 to 11, the heart valve graft 4 includes a valve stent 41 and a prosthetic leaflet 42 located inside the valve stent 41. The valve holder 41 includes a holder main body 411, a first stopper (a support 414 and an encryption rod 415), and a second stopper (a

valve clip

412 and 3 stopper rods 413). The stent main body 411 has an inner passage in the expanded state, and the artificial leaflet 42 is attached in the inner passage.

In this embodiment, the valve clip 412 is an integrally formed valve clip that is removably attached to the stent body 411. The holder body 411 comprises 3 first connecting portions 4111, the valve clip comprises 3 connecting

portions

4121 and 3 clamping portions 4122, the second connecting portions 4121 correspond to the first connecting portions 4111 and are detachably connected to detachably connect the valve clip to the holder body 411, and the clamping portions 4122 are configured to restrain the human valve leaflets between the holder body and the valve clip when the valve holder is in the working state. In the present embodiment, each of the clamping portions 4122 is V-shaped, each of the clamping portions has an arc bottom located at the proximal end and a pair of top ends extending from the arc bottom to the distal end, the top ends of the adjacent clamping portions are connected to form an arc top, and the second connecting portion 4121 is disposed on the arc top and extends to the distal end. In this embodiment, the first connecting portions 4111 are uniformly distributed along the circumferential direction of the holder body, the second connecting portions 4121 correspond to the first connecting portions 4111, and the 3 clamping portions 4122 are V-shaped clamps having the same size. In an alternative embodiment, the first connecting portions 4111 may not be uniformly distributed, and the clamping portions 4122 may be changed in size according to actual needs.

In the present embodiment, each of the clamping portions 4122 of the valve clip is centrally provided with a clamping reinforcement 4123, the clamping reinforcement 4123 being arranged to clamp the body leaflets to the outside of the stent body when the valve stent is in the working state. Specifically, the clamping reinforcing piece 4123 is provided with a connecting end and a free end, the connecting end of the clamping reinforcing piece is fixedly connected with the arc bottom of the clamping portion, the free end of the clamping reinforcing piece extends from the clamping portion to the far-end of the support and is arranged to be pressed against the human valve leaflet when the valve support is in a working state, the connecting end of the clamping reinforcing piece is in a single-rod design, the free end is in an annular shape, and the round-head design can avoid penetrating through the human valve leaflet.

Thus, the clamping reinforcing part 4123 is matched with the limiting rod 413 to clamp the human valve leaflet between the clamping reinforcing part and the limiting rod, so that on one hand, the clamping reinforcing part plays a role in reinforcing and fixing, and on the other hand, the human valve leaflet can be prevented from floating once being torn, so that the risk that the valve leaflet blocks a coronary orifice is reduced. In an alternative embodiment, the bottom of the valve clip can also include a depression (as shown in example 1). In an alternative embodiment, the valve clips may also be individual valve clips independent of each other. In an alternative embodiment, the attachment end of the clamp reinforcement 4123 may be a dual bar design (as shown in fig. 12).

[ example 5 ]

The valve clip of the heart valve graft of example 5 of the present invention is specifically described below with reference to fig. 13. Fig. 13 is a schematic perspective view of a valve clip of a heart valve graft according to example 5 of the invention.

The heart valve graft in this example differs from the heart valve graft in example 1 mainly in that the valve clip is also provided with visualization points.

As shown in fig. 13, the valve clip 512 has 3 connecting

portions

5121 and 3 clamping portions 5122, the connecting portions 5121 are elastic opening deformation members extending from the arc top to the distal end, and the arc bottoms of the clamping portions 5122 are provided with through holes 5123, which are filled with developing materials, so that the bottoms of the clamping portions have developing points, which is convenient for observing the positions of the bottoms of the clamping portions in the human body during the releasing process, thereby determining whether the arc bottoms reach the sinus of the human valve leaflets. In the present invention, the developing material may be a high density metal, such as gold, platinum, tantalum, palladium, iridium, tungsten, or combinations thereof, such as platinum-iridium alloy, platinum-tungsten alloy, and the like.

It should be understood by those skilled in the art that the foregoing is only illustrative of the present invention, and is not intended to limit the scope of the invention.

Claims

1. A heart valve graft comprising a valve stent and prosthetic leaflets located inside the valve stent, the valve stent comprising:

a stent body;

the first limiting part is arranged at the proximal end of the bracket main body and is used for limiting the valve bracket to move towards the distal end when the valve bracket is in a working state;

the second limiting part is arranged at the far end of the bracket main body and is used for limiting the valve bracket to move towards the near end when the valve bracket is in a working state.

2. The heart valve graft of claim 1, wherein the stent body comprises at least one first connecting portion, the second retaining member comprises a valve clip, the valve clip comprises at least one second connecting portion and at least one clamping portion, the first and second connecting portions are configured to removably connect, and the clamping portion is configured to trap a body leaflet between the stent body and the valve clip when the valve stent is in an operating state.

3. The heart valve graft of claim 2,

the bracket main body comprises a connecting piece, and the first connecting part and the second connecting part are detachably connected through the connecting piece.

4. The heart valve graft of claim 3, wherein the first and second connectors are each a flexible member having a raised resilient opening, the connector is a sleeve having a receiving cavity therethrough and a distal end of the sleeve extends to form a flexible stop, the receiving cavity is configured to allow the projections of the first and second connectors to deform and pass therethrough, the projections are configured to limit movement of the connector, and the stop is configured to limit deformation of the resilient openings of the first and second connectors after bending.

5. The heart valve graft of claim 3, wherein the first attachment portion defines a first hole and the second attachment portion defines a second hole, and wherein the attachment member is a suture or a metal loop that can be passed through the first hole and the second hole.

6. The heart valve graft of claim 2, wherein the clamping portion of the valve clip is centrally disposed with a clamping reinforcement member, the clamping reinforcement member having an attachment end and a free end, the attachment end of the clamping reinforcement member being fixedly attached to the clamping portion, the free end of the clamping reinforcement member extending from the clamping portion toward the distal end of the stent, the clamping reinforcement member being configured to clamp the body leaflet to the exterior of the stent body when the valve stent is in the operational state.

7. The heart valve graft of claim 2, wherein a bottom of the gripping portion of the valve clip comprises a recess configured to clamp the human valve leaflet to an exterior of the stent body when the valve stent is in an operational state.

8. The heart valve graft of claim 1, wherein the second retention element comprises at least one retention rod having a connecting end fixedly connected to the stent body and a free end extending outwardly from the stent body such that the retention rod axially bears against a human leaflet when the valve stent is in the operational state.

9. The heart valve graft of claim 8, wherein the free end of the stop bar is provided with barbs configured to catch a human leaflet when the valve stent is in the working state.

10. The heart valve graft of claim 1, wherein the first retaining member comprises a plurality of support members disposed circumferentially about and fixedly coupled to the stent body, the support members being configured to deploy outward from the stent body to limit distal movement of the valve stent when the valve stent is in the operational state, and wherein a cinch bar fixedly coupled to the stent body is disposed between adjacent support members.

11. The heart valve graft of claim 1, wherein the distal end of the stent body is provided with an interface for gripping by a delivery system.

12. The heart valve graft of claim 2, wherein a bottom of the clamping portion of the valve clip is provided with a through hole filled with a visualization material.